Thailand HDV Cohort

The HIV Netherlands Australia Thailand Research Collaboration

Status: Enrolling

Conditions: HDV

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05350865

HIV-NAT 304

Details and patient eligibility

About

There is very limited data of HDV in Thailand. As both HDV and HIV can accelerate the HBV course and increased the risk of death, particularly, among those with low CD4 cells/count, therefore, HDV burden in this special population is unmet need. Therefore, this study plans to perform a nationwide survey of the prevalence and predictor of HDV among people uses drugs (PWID) with and without HIV, HBV/HIV (MSM vs non MSM), HBV related cirrhosis. Findinds from this study will provide the scientific community to understand how important HDV is among HBV patients, this could be used to develop strategies for HDV screening and treatment

Full description

The prevalence of HDV remains ill-defined, mainly for lack of appropriate testing and screening. As both HDV and HIV can accelerate the HBV course and increased the risk of death, particularly, among those with low CD4 cells/count, therefore, HDV burden in this special population is unmet need. This data will inform the guideline whether HDV screening among HBV/HIV is required. This study has plans to perform a nationwide survey of the prevalence and predictor of HDV among people uses drugs (PWID) with and without HIV, HBV/HIV (MSM vs non MSM), HBV related cirrhosis. This Nationwide survey of HDV is collaboration between Thai liver society, Thai AIDS society, Thai Red Cross AIDS research centre, Faculty of Medicine Chulalongkorn University, and AIDS TB and STI Control Division, Department of Disease control, MOPH Thailand. All findings will be shared and discussed to develop the National guideline for screening, treatment and care.

Enrollment: 3,152 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female, aged 18 years and older

2. Chronically-infected with HBV, as defined by:

   Positive Hepatitis B surface antigen HBsAg) or HBV DNA result with a subsequent positive HBsAg or HBV DNA result at least 6 months after first positive result

3. Provide signed and dated informed consent form.

Exclusion criteria

Non chronic HBV

Trial design

3,152 participants in 1 patient group

HDV cohort

Description:

Chronic Hepatitis B (HBsAg+) with cirrhosis (APRI \>1.5, FIB-4 \> 3.25, Fibroscan \> 12.5, imaging), PWID with HBV, HIV/HBV, HBV/HCV, aged 18 years and older